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  • 18 December 2023

    Position paper Medical Device Lifetime

    The Team-NB Position Paper defines the lifetime of medical devices under the Medical Devices Regulation 2017/745. It addresses the lack of a specific definition…

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  • 24 March 2023

    Extension of the MDR transitional period

    New EU Regulation 2023/607 came into force on March 20, 2023, regarding the extension of the transition period for the MDR.

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  • 17 February 2023

    Extension of the Medical Devices Regulation (MDR) transition

    The European Parliament has voted to extend the Medical Devices Regulation (MDR) transition periods to avoid a shortage of life-saving products in the…

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  • 2 December 2022

    Submitting Technical Documentation under the MDR?

    Submitting Technical Documentation? Read the Team-NB Position Paper on Best Practice Guidance for the Submission of Technical Documentation under Annex…

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  • 15 September 2022

    Notified body capacity

    The MDCG recognizes that significant and urgent challenges remain in ensuring sufficient capacity of notified bodies and readiness of manufacturers in…

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  • 27 June 2022

    Manufacturers approach to the MDR bottleneck around May 2024

    MDCG 2022-11: a position paper of the MDCG about how manufacturers of medical devices may approach the MDR certification bottleneck in May 2024

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  • 2 May 2022

    Update MDSAP Audit Approach MDSAP AU P0002.007

    This revision includes the changes in Canadian adverse events and advisory notices reporting that took effect on June 23, 2021. Additionally, there were…

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  • 27 April 2022

    MDCG 2022-05 Guideline on borderline products

    This guidance covers all products on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.

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  • 25 January 2022

    The importance of the device label to a global UDI system

    The importance of the device label to a global UDI system

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  • 1 November 2021

    MDCG 2021-26 Q&A on repackaging & relabelling activities

    MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

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  • 7 October 2021

    New MDCG guidance document MDCG 2021-24

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  • 6 September 2021

    TUV Rheinland Italia designated Notified Body MDR

    TUV Rheinland Italia designated Notified Body MDR

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  • 14 May 2021

    Technical Boards of CEN and CENELEC accepted standardization request

    Technical Boards of CEN and CENELEC accepted standardization requests.

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  • 23 April 2021

    Update references of harmonised standards for medical devices

    The references of harmonised standards for medical devices under directives has been updated by the European Commission.

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  • 26 March 2021

    MDCG 2021-3 Questions and Answers on Custom-Made Devices (MDR)

    MDCG 2021-3 Questions and Answers on Custom-Made Devices (MDR).

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  • 12 January 2021

    Remote Notified Body Audits possible for MDR and IVDR

    Remote Notified Body Audits possible for MDR and IVDR.

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  • 7 December 2020

    Eudamed launched with actor registration module live

    The EC’s Eudamed database launched on Tuesday December 1 with the actor registration module available to member states and economic operators.

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  • 17 November 2020

    Embracing remote audits

    Lloyd's Register customers consider remote audits as robust as face-to-face audits.

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  • 24 July 2020

    MDCG 2020-13 clinical evaluation assessment report

    MDCG 2020-13 clinical evaluation assessment report, a core requirement of the Medical Device Regulation (EU) 2017/745 (MDR).

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  • 26 June 2020

    ISO/TR 24971:2020 Guidance on the application of ISO 14971

    ISO/TR 24971:2020 ISO/TR 24971:2020 Guidance on the application of ISO 14971.

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  • 21 April 2020

    MDR Date of Application 26 May 2021

    Last friday, April 17th, the proposal by the EU commission to postpone MDR 12 months was finally accepted by the EU parliament with 693 in favor, 1 against,…

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  • 31 March 2020

    Update harmonized standards for MDD & IVD directives

    The European Commission publishes an update of harmonized standards for Medical Devices & IVD directives.

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  • 27 March 2020

    Will MDR be postponed for a year?

    MDR would apply from May 26. Due to the impact of COVID-19 on national authorities and the medical device industry, the European Commission is asking for…

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  • 19 March 2020

    MDCG Offers MDR Implementation Plan, ‘Significant Change’ Guidance

    MDCG released guidance to provide clarification on the changes to devices under MDR Article 120(3).

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  • 21 February 2020

    NSAI 11th Notified Body MDR

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  • 14 February 2020

    "Worst case scenario" MDR and MDD realistic for third countries?

    Third country compliance for Swiss manufacturers for all products under MDR and MDD from 26 May 2020 is currently the realistic «worst-case scenario».

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  • 12 January 2020

    MDCG 2019-15 Guidance Notes Class I Medical Devices

    These guidance notes do not aim to be a definitive interpretation of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April…

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  • 14 December 2019

    DEKRA Certification B.V. designated under MDR

    DEKRA Certification B.V. is the 3rd Dutch notified body designated under the EU MDR

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  • 13 November 2019

    MDCG 2019-11 Software classification in the MDR and IVDR

    Last month the European Commission released MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation MDR and IVDR.

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  • 27 September 2019

    TÜV Rheinland 5th Notified Body MDR

    TÜV Rheinland 5th designated Notified Body under EU-MDR.

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  • 19 September 2019

    US asked to push back the deadline for the new EU MDR requirements.

    The United States has asked the European Union to push back the compliance deadline for the new EU MDR requirements by three years.

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  • 9 September 2019

    Worlds first MDR certificate issued by BSI

    BSI certified the first product to the Medical Devices Regulation.

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  • 14 August 2019

    DEKRA Germany 3rd NoBO under MDR

    DEKRA Germany is the 3rd NotifiedBody to receive designation against the EUMDR as listed on the Nando website.

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  • 12 July 2019

    LRQA dropping out as Notified Body

    Notified Body capacity is rapidly decreasing. Notified Body LRQA is dropping out of the Notified Body pool for medical devices and IVDs.

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  • 12 June 2019

    Virtual Manufacturing of Medical Devices

    The MHRA has published a new guidance with regard to "Virtual manufacturing of medical devices".

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  • 3 July 2018

    MDSAP Qualified Auditor

    After an extensive training, I passed the required exams and am now a qualified MDSAP auditor for DEKRA Certification BV. The first MDSAP audits have been…

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  • 13 June 2018

    GDPR compliant

    The structure of our website is now in compliance with the latest GDPR requirements.

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  • 13 April 2018

    Health Canada modifies MDSAP transition process

    Health Canada announce modifications to the transition process

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  • 19 January 2018

    FAQ transition timelines MDR/IVDR

    The Transition Sub Group (TSG) of the CAMD today presented the outcome of their discussions regarding transition-related provisions regarding the MDR (i.e.…

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  • 22 December 2017

    MDR/IVDR roadmap published

    The CAMD network is delighted to be able to publish the high-level Medical Devices Regulation/In-vitro Diagnostics Regulation (MDR/IVDR) Roadmap.

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  • 15 November 2017

    Human Factors and Usability Engineering

    Read the guidance from the MHRA on 'Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products

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  • 31 August 2017

    Interactive guidance MHRA

    Interactive guidance from MHRA published in EU-MDR and IVDR.

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  • 31 July 2017

    How ISO develops standards

    Like a symphony, it takes a lot of people working together to develop a standard. ISO’s role is similar to that of a conductor, while the orchestra is…

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  • 5 May 2017

    MDR / IVDR approved

    Medical devices: more safety, more traceability. That is how the EU reported today’s approval ...

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  • 3 May 2017

    EU MDR / IVDR publication close

    EU MDR and IVDR are getting close. Publication expected May 5, 2017. Get informed and take action...

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  • 5 April 2017

    ISO 13485:2016 published

    The countdown ended by the end of February 2016. The new ISO 13485:2016 is published! Compared to the 2003 version the following key areas need attention...

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  • 27 February 2017

    Final text MDR /IVDR for voting

    On 22 February 2017, the final text of the MDR and IVDR were published for voting on March 7, 2017.

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